BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE PEG

    MDR report key: 7638662 · Received June 26, 2018

    Report

    Report Number
    3010757606-2018-00368
    Event Type
    Death
    Date Received
    June 26, 2018
    Date of Event
    June 12, 2018
    Report Date
    June 12, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062941-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED IN MODEL #/LOT # WHICH IS THE US LIST NUMBER. THE DEVICE MANUFACTURER AND LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THE DEVICE INVOLVED WAS ABBVIE BRANDED TUBING. ABBVIE HAS CHOSEN TO REPORT THIS COMPLAINT DUE TO THE POTENTIAL THAT THE DEVICE INVOLVED COULD HAVE BEEN ABBVIE BRANDED TUBING. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. POST PROCEDURAL COMPLICATIONS ARE KNOWN COMPLICATIONS OF A PEG- J TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2018, THE PATIENT PULLED OUT THE PEJ COMPLETELY FOR AN UNKNOWN REASON. IT WAS PLANNED TO REPLACE THE PEJ TUBE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT HAD NOT RECEIVED DUODOPA SINCE (B)(6) 2018 AND THE PEJ WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481839 ABBVIE PEG TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention J TUBE, UNKNOWN MANUFACTURER